MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE TISSUE REMOVAL DEVICE.; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 30-401LITE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

Event Description

It was reported that during a myosure and hysteroscopy procedure on november 18th, the physician observed metal shavings in the uterine cavity.The physician attempted to remove all the metal shavings using dilation and curettage but was not successful.The physician decided to abort the procedure at this point thus cancelling a novasure procedure scheduled.The status of the patient is unknown.The physician reported that he was not able to remove all the debris from the uterus.The patient did not receive additional surgery nor medication.No other information is available.

Manufacturer Narrative

Myosure disposable received and tested.Visual inspection was performed, and there were no signs of physical damaged.Functional inspection was performed, and during the dissection test it was found the blade and outer tube was making unusual friction and blade was worn out, metal particles were found inside the handle.Hence the complaint can be confirmed.Complaint was confirmed/reproduced.We will continue to trend and monitor the reported condition.Corrective action not warranted at this time.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE.
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 13012594
• MDR Text Key: 284133459
• Report Number: 1222780-2021-00360
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045505070
• UDI-Public: (01)15420045505070(10)21H04RG(17)240719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 21H04RG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OMNI HYSTEROSCOPE
• Patient Outcome(s): Other